Transcarotid Artery Revascularization With Flow Reversal.

PURPOSE: To report a study evaluating the safety and efficacy of stenting via direct carotid access with flow reversal using the ENROUTE Transcarotid Neuroprotection System. METHODS: Between March 2009 and June 2012, 75 patients (mean age 72.6 years; 45 men) underwent carotid artery stenting with the ENROUTE System; the majority of patients (63, 84%) were asymptomatic. The primary safety endpoint was the composite of major stroke, myocardial infarction, or death at 30 days. Efficacy outcomes included acute device success, procedure success, and tolerance to flow reversal. Fifty-six (74.7%) patients underwent diffusion-weighted magnetic resonance imaging (DW-MRI) before and after the procedure to assess the development of new ischemic brain lesions. RESULTS: Acute device and procedure success were achieved in 68 (90.6%) patients. The reverse flow circuit was established in 71 (94.6%) patients; only 5 patients demonstrated transient intolerance to flow reversal that did not interfere with completion of the procedure. The mean time on flow reversal was 19.1 minutes. In the DW-MRI substudy, 10 (17.9%) of 56 patients had ipsilateral new white lesions with a mean volume of 0.17 mL. At 30 days, no major stroke, myocardial infarction, or death occurred; 1 patient had experienced a minor stroke that was adjudicated as not related to either the device or procedure. CONCLUSION: Results of the PROOF study demonstrate the safety and efficacy of transcarotid revascularization with the ENROUTE Transcarotid Neuroprotection System.

Developments in parallel grafts for aortic arch lesions.

Due to the shortage of commercially available off the shelf aortic arch grafts since the last years parallel grafts or chimney grafts have played an increasing role in the treatment of patients with aortic arch lesions. Although there are still issues with type endoleaks and gutters between the chimney graft and the aortic stent-graft remaining. We report our results with the Medtronic thoracic graft in combination with long self-expanding parallel grafts, to ensure an overlapping zone of more than 7 cm between the different grafts. Alternatively, sandwich configurations are used where a direct contact between the parallel graft and the aortic wall is avoided. We have placed a total of 65 parallel grafts into supra-aortic branches. In 21 cases chimney grafts were placed into the carotid artery, in most cases into the left common carotid artery. In 36 cases chimney grafts were placed into left subclavian artery. A maximum number of 4 parallel grafts were placed for total endovascular debranching. In addition, in 8 patients a parallel graft had to be placed into the innominate artery. There was a patency of 69% for all subclavian artery chimney grafts versus 73% for carotid artery parallel grafts. Of note is a stroke rate of 5.2% in all these cases. Only 2 of the patients with an occluded left subclavian artery chimney graft required a bypass procedure for arm claudication or ischemia. We had a primary type I endoleak rate of 28%. In almost 25% secondary interventions were required mainly to treat type I leaks, in those cases where the leak did not resolve spontaneously. The overall mortality rate was 3.5%. The results of parallel graft in the aortic arch are promising, but of major concern is still the high rate of type I endoleaks as well as the neurological complication rate, most probably due to catheter manipulation in patients with severe atherosclerotic arch lesions.

Experience with the sandwich technique in endovascular thoracoabdominal aortic aneurysm repair.

BACKGROUND: The sandwich technique is an endovascular off-the-shelf solution for patients with thoracoabdominal aortic aneurysms (TAAAs). In a sandwich configuration, the chimney stent runs in the middle of a space created by two or three aortic endografts. METHODS: All patients with TAAAs who were treated with the sandwich technique were included in the study. Self-expanding Viabahn grafts (W. L. Gore and Associates Inc, Flagstaff, Ariz) were used as parallel grafts in the renal arteries and visceral vessels. Caudad-facing chimney grafts were used for the visceral arteries and cephalad-facing periscope grafts for the renal arteries. RESULTS: During the study period, 32 patients with TAAAs were treated with sandwich grafts. Indication for the procedure in 43% was an acute onset of symptoms, including two patients with a rupture and a retroperitoneal hematoma. Three patients required an additional debranching procedure. A total of 104 chimney grafts were implanted. Two patients died postoperatively because of the operation. Major adverse events were recorded in five patients, including one patient with persistent paraplegia and two with permanent renal failure requiring dialysis. The incidence of chimney graft occlusion was higher in patients with three or four parallel grafts than in those with two chimney grafts only. Patients with chronic dissections had a 12-times higher incidence of chimney graft occlusion than aneurysm patients. The number of patients with type I or III endoleaks was higher in the group with three or four parallel grafts. CONCLUSIONS: The sandwich technique is an off-the-shelf endovascular alternative to treat patients with TAAAs in an emergent setting. The combination of chimney grafts with a periscope configuration enables a rapid endovascular aneurysm exclusion with acceptable midterm results.